Single Use GonioPro Surgical Multi-Port Stabilizer (VSGSBD)

GUDID 10811608019915

VOLK OPTICAL INC.

Gonioscope
Primary Device ID10811608019915
NIH Device Record Key098aad7c-48c8-4f99-9377-d819ba26db9f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle Use GonioPro Surgical Multi-Port Stabilizer (VSGSBD)
Version Model NumberVSGSBD
Company DUNS071125835
Company NameVOLK OPTICAL INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100811608019918 [Primary]
GS110811608019915 [Package]
Contains: 00811608019918
Package: Box [10 Units]
In Commercial Distribution
GS120811608019912 [Package]
Contains: 00811608019918
Package: Carton [100 Units]
In Commercial Distribution
GS130811608019919 [Package]
Contains: 00811608019918
Package: Case [800 Units]
In Commercial Distribution

FDA Product Code

HKSPrism, Gonioscopic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-12
Device Publish Date2026-02-04

Devices Manufactured by VOLK OPTICAL INC.

00811608019895 - GonioPro Surgical Lens + Handle (VSGLHACS)2026-02-12
10811608019908 - Single Use GonioPro Surgical Single-Port Stabilizer (VSGSAD)2026-02-12
10811608019915 - Single Use GonioPro Surgical Multi-Port Stabilizer (VSGSBD)2026-02-12
10811608019915 - Single Use GonioPro Surgical Multi-Port Stabilizer (VSGSBD)2026-02-12
10811608019922 - Single Use GonioPro Surgical Lens + Single-Port Stabilizer (VSGLSAD)2026-02-12
10811608019939 - Single Use GonioPro Surgical Lens + Multi-Port Stabilizer (VSGLSBD)2026-02-12
10811608019946 - Single Use GonioPro Surgical Lens + Handle (VSGLHD)2026-02-12
00811608019802 - Rapid SLT2025-08-15
00811608019819 - 20D Limited Edition #22025-08-11

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